Cosmetics GMP is a set of guidance provided to cosmetic enterprises to comply with in order to ensure product quality and safety.. Good Manufacturing

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2 Cosmetics GMP is a set of guidance provided to cosmetic enterprises to comply with in order to ensure product quality and safety.. Good Manufacturing Practices (GMP) Guidelines cover all aspects of the manufacturing of cosmetic products from starting material to finished products.

3 WHY IS REGULATION NECESSARY? UNSCRUPULOUS MANUFACTURERS Harmful Ingredients Preservatives & Fragrances Allergies Corticosteroids Dermatitis Permanent Damage Hydroquinone Mercury Salts Steroids

4 Where & when did regulation start? 1938 GMP practices are Enforced Food, Drug, and Cosmetic Act 1992 FDA Cosmetic GMP Guidelines prohibiting adulterated or misbranded products ISO (TC 217) (WG 6) start on s GMP-enforced in Pharmaceutic al industry in US and Europe European (Colipa) Guidelines on Cosmetic GMP GMP Guidelines by the Council of Europe 2006 Draft standard approved by ISO TC 217 WG European Cosmetic Regulation 76/768 EWG Request by EU Member to publish a new set of GMP Guidelines ISO GMP for Cosmetic Products published

5 Technical Committee (TC 217) is responsible for cosmetic products Working Group (WG 6) : GMP for cosmetic products

6 Participating Members TC217: published November 2007 CASIC 6

7 INTERNATIONAL APPROACH REGULATED INTERNATIONAL ENVIRONMENT As of 11 July 2013, the European Union As of, the European Union s new Regulation (EC) No 1223/2009 will require ALL cosmetic products to be manufactured according to Good Manufacturing Practices (GMP). One way to demonstrate compliance with GMP is to implement the international standard ISO 22716:2007.

8 SABS - released SANS 22716:2011 on the 17 th of August 2011 The Cosmetic, Toiletry & Fragrance Association (CTFA) Compendium is being updated and will be released September 2011

9 THE CONCEPT OF ISO Basis for Implementation: Product safety Consumer protection GMP concept is based on: Product Quality Reproducibility of Processes Conformity to Specifications Traceability of Products Risk assessment in respect of: Processes & Products

10 Purchasing Reception Manufacturing Packaging Storage Maintenance Engineering Control Laboratories Quality /QA Shipment

11 ETC

12 1. Scope: This International Standard gives guidelines for the production, control, storage and shipment of cosmetic products. The next few slides outline the guidelines / requirements of the standard Almost every guideline have a principle to adhere to 2. Definitions

13 Organization Chart- adequate staff Key responsibilities Training Personnel hygiene & health linked to the protection of the product

14 Persons involved in the implementation of the activities described in these guidelines should have appropriate training to produce, control and store products with a defined quality.

15 Design- space- flow- floors, walls, ceilings & windows Washing & Toilet facilities Lighting Ventilation Pipework, drains & ducts Cleaning & Sanitization Maintenance Pest Control

16 Premises should be located, designed, constructed and utilized so as to: a) Ensure protection of the product; b) Permit efficient cleaning, if necessary, sanitizing and maintenance; c) Minimize the risk of mix-up of products, raw materials and packaging materials.

17 Design (prevent contamination) Installation (ease drainage) Calibration of Measuring instruments Cleaning & Sanitization Maintenance of Equipment

18 Equipment should be suitable for the intended purpose and capable of being cleaned and, if necessary, Sanitized and maintained. This clause applies to all equipment within the scope of these guidelines. If automated systems are introduced into activities described in these guidelines, they should take into account the application of the given relevant principles.

19 Purchasing Receipt Identification & Status Release Storage Re-evaluation Quality of Water in Production

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21 Availability of Relevant Documents Start-up checks Batch numbers In-process identification In-process controls Bulk product storage Packaging operations

22 At each stage of manufacturing operations and packaging operations, measures should be taken to produce a finished product that meets the defined characteristics.

23 Release Storage Shipment Returns

24 Finished products should meet the defined acceptance criteria. Storage, shipment and returns should be managed in a manner so as to maintain the quality of finished products.

25 Test methods & Acceptance criteria Results & Out-of of-specification results Identification of Reagents, Solutions, Reference Standards, Culture media Sampling & Retainer samples

26 9.1.1 Principles described for personnel, premises, equipment, subcontracting, and documentation should apply to the quality control laboratory The quality control laboratory is responsible for ensuring that the necessary and relevant controls,, within its activity, are carried out for sampling and testing so that materials are released for use and products are released for shipment, only if their quality fulfils the required acceptance criteria.

27 Rejected finished products, bulk products, raw materials and packaging materials Reprocessed finished products and bulk products

28 Types of waste Flow Containers Disposal

29 Types of subcontracting Manufacturing, packaging, analysis, cleaning & sanitization of premises, pest control, maintenance Contract Giver Contract Acceptor The Contract

30 A written contract or agreement should be established, mutually confirmed and controlled between the contract giver and the contract acceptor covering subcontracted activities. The objective of this step is to obtain a product or service that complies with the defined contract giver requirements.

31 13. Deviations Authorized with sufficient data to support the decision. Corrective action to prevent recurrence 14. Complaints & Recalls

32 All complaints that fall within the scope of these guidelines and are communicated to the plant should be reviewed, investigated and followed-up on, as appropriate When a product recall decision is made, appropriate steps should be taken to complete the recall within the scope of these guidelines and to implement corrective action In the case of contracted operations, the contract giver and acceptor should agree on the process for managing complaints (see 12.1).

33 Internal Audit Approach-specially designated personnel Follow-up corrective action

34 An internal audit is a tool which is designed to monitor the implementation and the status of these cosmetic Good Manufacturing Practices and, if necessary, to propose corrective actions.

35 17. Documentation Activities should be documented Documentation Management Type of documents Writing, approval & distribution Revision Archiving

36 17 Documentation Each company should establish, design, install and maintain its own system of documentation that is appropriate to its organizational structure and to the type of products. An electronic system can be used to prepare and manage documents Documentation is an integral part of GMP. Therefore, the objective of documentation is to describe activities defined in these guidelines in order to relate the history of these activities and to prevent risks of interpretation, loss of information, confusion or errors inherent to verbal communication.

37 Improving production quality management Defining and managing critical points in production Reducing the number of complaints Defining competencies and responsibilities Confirming implementations of legislative requirements

38 TRAINING INFRASTRUCTURE REPONSIBILITIES & AUTHORITY PURCHASING PRODUCTION & IN-PROCESS CONTROL OUT-OF OF- SPECIFICATION / NON CONFORMANCE INTERNAL AUDIT DOCUMENTATION MEASURING EQUIPMENT ANALYSIS AUDITS

39 With thanks to Eize de Boer CVO-EUROPE Et al